The information age has provided many pluses with regard to the amount and quality of information available to everyone. This is especially true in the health care field because physicians and other health professionals now have access to large quantities of data on any subject in a short amount of time. However, attempts to access specific, desired information usually results in an unstructured “data dump” that is typically not responsive to these specific or specialized needs of the physician or health care professional. Taking the appropriate actions for a specific problem for a specific patient requires an ability to tailor this access to the vast amount of medical knowledge based on the specific medical needs of a particular patient. This type of tailoring, if it was available, would be of great help and would save time. More specifically, this tailoring would reduce the time needed to reach decisions about treatment and would improve the quality of medical care by insuring that physicians were always armed with the medical knowledge required to swiftly diagnosis and treat each specific medical problem of each patient.
The foregoing, if available, would result in an increase in the productivity of the health care system by making physicians and other facets thereof more responsive and efficient. It will also enhance the quality of care given to individual patients, and preserve, in a useful form, the work product of the health care system—the medical files of patients that have been treated.
Any increase in the efficiency of the health care system must take into account certain other factors. Examples of some of these are:                (i) the physician-patient relationship,        (ii) the continuing medical education of physicians,        (iii) the rapid introduction into clinical practice of advances in knowledge about disease,        (iv) the rapid deployment of newly approved medications,        (v) the reduction of medical liability costs,        (vi) the reduction in the practice of “defensive medicine,”        (vii) the planning and execution of medical research,        (viii) the monitoring of medical practice habits,        (ix) patient education and treatment compliance,        (x) preventive medicine to reduce morbidity, and        (xi) the cost of health care.        
The considerations referred to above will require re-engineering of the current health care system to increase its efficiency. When this is done, it will overcome the endemic problems in the system which have been the widely acknowledged to include: high and escalating costs of health care in the United States and worldwide and lack of a uniform quality of care in all areas where health care is administered. There also are serious problems in the ability of the health care system to address emerging issues in health care in more than a purely localized way.
Physicians, for example, are under pressure to increase the number of patients that they see and also reduce the time spent with each, individual patient. This, among other things, results in an erosion in the physician-patient relationship. This, in-part, is based on physicians having little time to assess patient needs, develop the most correct and efficient plans for treatment, or establish a rapport with the patient.
A review of typical medical practice habits indicates that “patient history taking” suffers most when stringent time constraints are put on physicians or other health care professionals. On the other hand, a time-intensive process, such as this, is needed now more than ever, given the efficacy of drugs and physical actions for prolonging not only life but the quality of life.
“Patient history taking” has been a constant in the practice of medicine. This procedure requires more of the physician's time than any other aspect of physician-patient interaction. In most cases, physicians are not remunerated at fair value for the time spent with patients in “patient history taking.” For example, in “health maintenance organizations” (“HMOs”), a physician's remuneration is tied directly to the numbers of patients seen and number of procedures performed rather than the time, effort, and quality of the medical care provided. This approach is unfortunate and dangerous given that the “patient medical history” is the single most important event of the physician-patient interaction. Experience has shown that when a thorough “patient medical history” is taken, a correct diagnosis can be made, in at least 80% of patients. The patient's medical history, therefore, is of paramount importance to physicians for making efficient, rational medical care decisions.
Another important facet of the physician-patient interaction that suffers when physicians have less time to spend with patients is the reduction in the information that patients learn about their disease. This will include the nature of their disease, the importance of treatment compliance, and patient activities that can control the outcome of their illness, to name a few.
The current health care environment requires alternative methods for obtaining and maintaining a patient's complete medical history, reading and evaluating the information in a medical history (which may be in the form of check-off forms completed by patients), and educating patients about their illnesses. These alternative methods have been needed long before now and they were even needed during times when “fee for service medicine” was apparently at its height. Since physicians are best suited to understand a patient's medical history and other medically relevant facts, these alternative methods have not been, and continues not to be, implemented because they would be administered by lay people, not physicians.
The development of a proper patient history follows a logical process based on extensive knowledge of clinical medicine, physiology, and pathophysiology. It is not, as many non-physicians believe, merely a compilation of data amassed through the use of check-off forms or by a scribe. Accordingly, methods are needed to obtain and maintain a patient's full history while holding down costs.
The present health care system lacks the ability to keep physicians up-to-date with respect to the latest developments in medical science. This includes developments in disease diagnosis and treatment in highly specific instances. Many disparate factors contribute to this problem. A first is that the number of new methods for diagnosis and treatment of disease is expanding at exponential rates. This wealth of new and innovative diagnosis and treatment procedures, along with the wealth of existing knowledge, however, create of formidable challenge for physicians if they attempt to master it. This is particularly true since the formal period of medical education, i.e., medical school, internship, and residency training, is decreasing and a large number of practicing physicians do not have ready access to the information.
This problem is not solved merely by increasing the formal aspects of medical education. Even if this was done, physicians would not have the needed information because the range of knowledge and experience required to practice state-of-the-art medicine increases daily. Moreover, the obsolescence of medical information is so rapid that the information that a physician learned in formal medical training a short time before is often no longer state-of-the-art medicine. No one physician can know and recall on demand more than a small portion of the total wealth of medical knowledge that applies to a specific disease. It does not matter how intelligent or knowledgeable the physician; there will be a gap between a particular physician's knowledge and a real state of medical knowledge.
High quality patient care increasingly relies on a physician knowing the very specific details about particular diseases and the treatment regimens for such diseases. This includes knowledge of, and familiarity with, what is known by highly trained sub-specialists in the different fields of medicine. It also may be directed to areas in which a particular physician has gained little or limited expertise during his or her medical training. These are diametrically opposed issues in health care for physicians. Accordingly, physicians must: (i) find a way to have full knowledge of established, and new and innovative diagnosis and treatment procedures and (ii) obtain this knowledge with less time to do it. The present health care system, however, charges ahead without a solution to these problems believing that physicians with less training and expertise will still be able to provide high quality care.
The seemingly daily advances in medical research have created for physicians unprecedented opportunities to have a positive impact on the lives of their patients. There are serious problems in physicians availing themselves of this new information in a manner in which they can immediately impact the care of their patients. Because of this problem, there is a widening gap between the knowledge physicians possess and the information that is actually available. This means the losers are the patients.
There is ample evidence for this gap. For example, common diseases, e.g., diabetes, abnormalities of blood lipids (that predispose to heart disease), and high blood pressure, are often under treated or not treated at all. This is because the physician does not know the most current or even the complete methods for the accurate diagnosis and treatment of the patient's conditions. This reflects the physician's lack of experience and his/her lack of continuing educational training in managing diseases. This difficulty in keeping practicing physicians fully informed is becoming more acute with each passing day because of their inability to know of and prescribe new drugs or understand how to use new procedures.
The “knowledge gap” can only be narrowed through continuing medical education (“CME”). Current methods for CME are abstract and usually not relevant to the specific, immediate needs physicians have in caring for their specific patients. CME, as it is administered now, requires large amounts of physician time outside of the clinically productive environment in which physicians work. Moreover, it is expensive. Today's CME programs are narrow in scope and focus, and ineffective in addressing the knowledge gap. Even when CME is considered effective, it does not solve a physician's almost impossible task of recalling selective pieces of information he or she receives. As such, it is not readily available for diagnosis and treatment of a diverse array of patients.
Another problem with the current state of the health care system is the in which medical records are kept and transferred from physician to physician (when needed). The health care system as we know it has no way of extracting important and needed knowledge from one of its most important work products, which is: the records of all patients who are treated. That is, millions of patients are treated and cared for each year, but the demographics, epidemiology, and records of patients' diseases, as well as the outcomes from treatment, are kept in a form that prevents general use of this information.
On Aug. 4, 1999, The NY Times® (“Times”) is a registered trademark of New-York Times Company) reported that the health care system in effect was not using the information with which it is imbued in an effective way. The Times article cited a study showing that treatment with Ritalin did not lead to higher subsequent rates of drug abuse in male patients, as previously believed. The conclusion that Ritalin had no adverse effect on the subsequent incidences of drug abuse was based on results from only 75 patients. The article also indicated that approximately 1.5 million male patients were taking Ritalin in the United States. It, however, did not comment on the sample error that is the result of only a 75 patient sample set and the non-inclusion of the remaining 99.995% of the total number of men that could have been part of the survey. The reason that no more than 75 patients were part of the sample set is the manner in which medical records are acquired and maintained. This problem made it next to impossible to obtain relevant data from the remaining 1,499,925 patients that were not included in the Ritalin study.
A yet further problem of the current health care system is its inability to pre-vent the serious complications of disease processes by the early identification of people who are affected prior to the onset of these complications. The key to solving this problem is having adequate resources to conduct population surveys of healthy people to find evidence of incipient disease. Since collective records of such patients are not available, the costs of such population surveys, if they could be done at all, would require a great deal of physician time—time that physicians do not have.
There have been attempts to solve some of the problems discussed. There have been computer-based methods for acquiring medical histories from patients. These systems diagnose disease under limited circumstances. For example, U.S. Pat. No. 4,130,881 discloses that a patient's medical history can be acquired and recorded using computer technology. This system, however, does not provide any method for the interpretation of the historical data, guidelines for the further evaluation of the historical data, easy incorporation of advances in knowledge, and or the like.
Further, U.S. Pat. Nos. 4,7,12,562, 4,838,275, and 5,012,411 use computers in a different way than U.S. Pat. No. 4,130,881. The systems described in the '562, '275, and '411 patents use computers for interpreting and analyzing physiologic data acquired by electronic monitoring of a patient. This interpretation and analysis is directed to rudimentary types of measurements, such as heart rate and blood pressure, for the purpose of treating blood pressure.
Another computer-based system is described in U.S. Pat. No. 5,868,699 and other patents by its inventor, Illiff. The '699 patent is directed to systems that use a computer to implement an expert system to provide a diagnosis based on a patient's medical history. These systems are of the type for providing patients with guidance to determine if he/she should seek medical advice. The data upon which these systems rely is based on an analysis of symptom complexes associated with the 100 most common complaints that patients have in the United States. The diagnoses that are provided are based on several assumptions about the practice of medicine. These assumptions include:                (i) that the method for diagnosis from an historical data base does not change,        (ii) that disease entities that represent the 100 most common symptom complexes are singular,        (iii) that accurate diagnoses can be made from historical data alone or with data from a patient's self examination,        (iv) that face-to-face interactions between patient and physician add no value to the diagnosis of disease, and        (v) that patients can determine the best treatment for their disease from tabulated arrays of diagnoses and drugs.The history component of the current invention is not based on these or any other assumptions.        
The system described in the '699 patent and other patents by inventor Illiff require expert input from the patient in the form of conclusions as to the organ causing symptoms. Alternatively, when the patient (the user) cannot provide such expert input, these patents disclose that the user is asked for his or her expert conclusion as to the cause of the symptoms.
The '699 patent and other patents by inventor Illiff also require that the user fill out questionnaires. These questionnaires are transmitted to the patient by facsimile or mailed for the purpose of completing relevant historical facts omitted during the initial, computer-based interrogation of the patient. These two sets of information eventually form the basis of a patient's medical history.
The '699 and other patents by inventor Illiff depend on the knowledge, training, and skill of a computer programmer for investigating specific answers to any and all questions in a patient's history. The prior art specified by inventor Illiff makes important assumptions during the collection of data for the history which may result in an incomplete medical history for diagnosing disease, i.e., the assumption that some types of information have importance and other types does not with regard to the immediate problem.
U.S. Pat. Nos. 3,566,370 and 4,130,881 describe systems that use a computer to acquire information for a patient's medical history. These patents are directed only to this limited task. These patents do not state the purposes for acquiring the histories except for review by a physician or other health care provider. In the '370 and '881 patents, the patients have to select for themselves, whether they are using the medical history facility for the first time (for an initial history) or for a subsequent time (for a follow-up history). Moreover, in the limited aspect of acquiring a medical history, the '370 and '881 patents describe methods that depend on the patient's ability to discern the organ that is the site of their disorder or discomfort.
Lastly, the medical histories, according to the '370 and '881 patents, require that the entire history that is collected be read and interpreted by the physician or any other person intending to render care to a patient.
U.S. Pat. No. 5,666,953 describes a method for collecting and digitizing data acquired by a monitoring device attached to a patient. U.S. Pat. No. 5,897,493 discloses a system to monitor patients with chronic diseases at home using devices that might for example monitor blood sugar in a diabetic. The peripheral monitor is connected to a central computer, which might query the patient depending on the value of the blood sugar. The system in the '493 patent is limted to a single disease entity per patient or peripheral device. It is limited to chronic diseases with features susceptible to monitoring by peripheral devices attached to a patient. It is not open to inputs outside the strict limits of the input from the peripheral monitoring device and associated built-in questions. Further, it does not include a method for exploring the presence or absence of disease outside the limits of the monitored system nor does it have diagnostic features. The system of the '493 patent has no educational features outside the limited area of the monitoring device and does not have features for building databases for the purpose of clinical research across a broad array of diseases. Finally, the system does not automatically notify doctors or patients of changes in the state of art informing the practice of medicine in any area of medicine.
U.S. Pat. No. 5,235,510 discloses a method for collecting and digitizing imaging data, e.g., an MRI scan and a CAT scan. The method then using a computer to analyze and interpret the medically relevant data. The method described in the '510 patent digitizes image data to provide medically relevant interpretations of such digitized images.
U.S. Pat. No. 5,687,716 describes a computer-based method that uses statistical methods to diagnose a patient's medical problem. The system of the '716 patent is limited to the analysis of parameters that are obtained by clinical testing and converted to numerical expressions. According to the '716 patent, any type of statistical method, including neural network analysis of a database of laboratory results, can be used to search for a deeper meaning in the data than might be apparent from a physician's interpretation of the same data. The method of the '716 patent operates under the assumption that patients can be separated, for this purpose, into those considered normal and those for which the analysis indicates the presence of disease. The analysis described in the '716 patent is the basis by which that system operates to enhance the productivity of the medical care system or to improve its quality. The method in the '716 patent does not interact directly with the patient to acquire historical data. Nor does it interpret laboratory data in the total context of all other clinical data.
U.S. Pat. No. 5,544,044 discloses a method for computer-based analysis of health claims forms in order to evaluate the quality of care received by a given set of patients, enrolled in a specific health plan, with a specific, given illness. The method of the '044 patent is severely limited in its capacity to estimate the quality of health care rendered. The system of the '044 patent has the ability to examine health care only at a single instant in time and it can do this only after health care has been rendered. There are no other uses described for this invention. The system described in the '044 patent operates based on the assumption, which is programmed into its analytic algorithm, that all patient's with the same, given coded diagnosis have identical medical profiles. This analysis of medical records or health claims files is inherently incorrect and can lead to faulty conclusions about the quality if care being rendered.
The present invention overcomes the problems set forth above as will be described in the remainder of the specification referring to the drawings.